USA/FDA

The CRO Group assists in preparation and submission of product approval applications including 510(k) Premarket Notifications and PMA Premarket Approval Applications, as well as 513(g) determinations and DeNovo petitions.  We're also well versed in preparing your company for FDA inspection under 21 CFR 820, The Quality System Regulation, 21 CFR 1270, The Human Cell and Tissue Regulation, and 21 CFR 812, Investigational Device Exemption.

For international medical device and or IVD manufacturers, CRO Group is a US Agent and may act as your official correspondent in accordance with US regulations.  For more information and or a quotation, click here.

For more information on our 510(k) services and other submission support services, click here.

For more information on our QSR services, click here.

CRO Group specialises in assisting all regulated (medical device, biologic, pharmaceutical) comply with 21 CFR 11 (Part 11 - Electronic Signature, Electronic Records) requirements.  For more info, click here.